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FDA 510(k)

Ambu aScope RLS Slim

K-Number: K181286 · 2018-11-30

ApplicantAmbu A/S
Decision Date2018-11-30
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Ambu aScope RLS Slim is the device name listed in this FDA 510(k) record. The listed applicant is Ambu A/S. It received FDA 510(k) clearance on 2018-11-30 under 510(k) number K181286. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ambu aScope RLS Slim?

Ambu aScope RLS Slim is a medical device that received FDA 510(k) clearance on 2018-11-30. The listed applicant is Ambu A/S. The 510(k) number is K181286.

When did Ambu aScope RLS Slim receive FDA 510(k) clearance?

Ambu aScope RLS Slim received FDA 510(k) clearance on 2018-11-30, under 510(k) number K181286.

Who is the listed applicant for Ambu aScope RLS Slim?

The FDA 510(k) record lists Ambu A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ambu aScope RLS Slim?

The FDA product code for Ambu aScope RLS Slim is EOB.

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Related Devices (Code: EOB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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